Cleared Traditional

ALFIS Vitamin D, ALFIS-3 Analyzer

K221817 · Immunostics Inc., · Chemistry
Sep 2023
Decision
457d
Days
Class 2
Risk

About This 510(k) Submission

K221817 is an FDA 510(k) clearance for the ALFIS Vitamin D, ALFIS-3 Analyzer, a System, Test, Vitamin D (Class II — Special Controls, product code MRG), submitted by Immunostics Inc., (Eatontown, US). The FDA issued a Cleared decision on September 22, 2023, 457 days after receiving the submission on June 22, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1825.

Submission Details

510(k) Number K221817 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2022
Decision Date September 22, 2023
Days to Decision 457 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MRG — System, Test, Vitamin D
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1825

Similar Devices — MRG System, Test, Vitamin D

All 45
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
K232587 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Apr 2024
Access 25(OH) Vitamin D Total
K223503 · Beckman Coulter, Inc. · Jan 2023
Elecsys Vitamin D total III
K210901 · Roche Diagnostics · Sep 2021
ADVIA Centaur Vitamin D Total (VitD)
K200509 · Siemens Healthcare Diagnostics, Inc. · May 2020
MAGLUMI 2000 25-OH Vitamin D
K191499 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Aug 2019
BioPlex 2200 25-OH Vitamin D Kit
K180577 · Bio-Rad Laboratories · Jun 2018